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Serving leading biopharmaceutical companies globally:

Dow
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Generated: October 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206793

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NDA 206793 describes CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, which is a drug marketed by Cypress Pharm, Jubilant Generics, Perrigo R And D, Allied Pharma Inc, Silarx, Sun Pharma Global, Taro, Aurobindo Pharma, Amneal Pharms, Tris Pharma Inc, Bio Pharm Inc, Actavis Mid Atlantic, Ranbaxy Labs Ltd, Apotex Inc, Sandoz, and Novel Labs Inc, and is included in eighteen NDAs. It is available from sixty-five suppliers. Additional details are available on the CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY profile page.

The generic ingredient in CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and sixty-one suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.

Summary for NDA: 206793

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 206793

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
cetirizine hydrochloride
TABLET, CHEWABLE;ORAL 206793 ANDA Novel Laboratories, Inc. 40032-652 40032-652-03 1 BOTTLE in 1 CARTON (40032-652-03) > 30 TABLET, CHEWABLE in 1 BOTTLE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
cetirizine hydrochloride
TABLET, CHEWABLE;ORAL 206793 ANDA Novel Laboratories, Inc. 40032-652 40032-652-10 1000 TABLET, CHEWABLE in 1 BOTTLE (40032-652-10)

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, CHEWABLE;ORALStrength5MG
Approval Date:Mar 8, 2016TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, CHEWABLE;ORALStrength10MG
Approval Date:Mar 8, 2016TE:RLD:No


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